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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUFLEXXA HYALURONIC ACID

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EUFLEXXA HYALURONIC ACID Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Fainting (1847); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Concussion (2192); Urinary Frequency (2275); Polydipsia (2604)
Event Date 05/17/2017
Event Type  Injury  
Event Description
First time getting injection. Had injection in both knees on (b)(6) 2016 in the afternoon. Had some pain and pressure in right knee but not the other. Felt okay after walking, followed instructions of not lifting any weight, taking it easy, walking, did not stand for more than 1 hour according to instructions; 8 or 9 at night started urinating until 3am in the morning, every 20 minutes. I do not have diabetes and i was drinking water throughout the night to replenish. Then got nauseous, which lead to diarrhea. Felt so sick, tried to get up to go to couch to lay down and then fainted because low blood pressure. Hit my head and i got a concussion and now i have stitches behind my ear.
 
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Brand NameEUFLEXXA
Type of DeviceHYALURONIC ACID
MDR Report Key6647190
MDR Text Key77860795
Report NumberMW5070463
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/14/2017 Patient Sequence Number: 1
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